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Knee OsteoarthritisPhase 4DIA IIT_01NCT03404479

Trial to Evaluate Efficacy and Safety of Combination of Diacerein and Celecoxib Administered in Patients With Knee OA

A Phase 4 study testing Diacerein and Celecoxib in people with Knee Osteoarthritis, run by Whan-Seok Choi at 2 sites in South Korea.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The purpose of this study is to evaluate the pain relief effect of Co-administration of Diacerein with Celecoxib in patients with knee osteoarthritis compared with single administration of each drug. Read more about this study

Who is it for?
Ages 50 years and older
Conditions the study is for
Knee Osteoarthritis
What is being tested?
Diacerein and Celecoxib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
2 sitesSouth Korea
Study dates
25 Jan 2018to 2 Jan 2019
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subjects who voluntarily consented, after listening enough explanation for this study and investigational product.
  • Adult over 50 years of age.
  • At least one of the knee pain VAS score is 40mm or more.
  • Meets the ACR(American College of Rheumatology) criteria for diagnosis. (1) Confirmation of osteophytes on radiographic inspection. (2) One or more of the following three items.
  • ① Age> 50 years
  • ② Morning stiffness <30 minutes
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  • ③ Crepitus
  • Patients who require medication for more than 12 weeks due to osteoarthritis symptoms.
  • Those who are able to follow the requirements of this clinical trial, such as being able to trace during the clinical trial period and to read and write the VAS questionnaire.
  • Those who weigh more than 40kg

Who cannot join

  • Secondary knee osteoarthritis
  • Other inflammatory Knee Osteoarthritis (e.g. gout, rheumatoid arthritis, etc.)
  • Patients presenting with gastroesophageal reflux disease, peptic ulcer.
  • Helicobacter infected patients who have not been treated for eradication (recruitment if negative in re-examination after treatment).
  • Short bowel syndrome that can cause inflammatory bowel disease (ulcerative colitis, Crohn's disease) and drug absorption disorder.
  • Intestinal obstruction syndrome
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  • Unexplained abdominal pain
  • ALT(Alanine aminotransferase) level of liver function test exceeded 5 times of reference range
  • Total bilirubin level exceeded 2 mg / dL
  • Serum albumin level less than 2 g / dL
  • Ascites
  • Hepatic encephalopathy
  • Hepatitis B, hepatitis C (excluding healthy carriers) or HIV positive
  • MDRD(Modification of Diet in Renal Disease) Estimated Glomerular filtration rate less than 60 mL / m2
  • Patients with hyperkalemia (over 5.5 meq / L)
  • history of asthma, acute rhinitis, nasal polyps, angioedema, urticaria or allergic reactions to aspirin or other non-steroidal anti-inflammatory drugs(including COX-2 inhibitors).
  • Malignant tumors other than basal cell or squamous cell carcinoma of the skin, CIN(Cervical Intraepitherial Neoplasia) and CIS(Carcinoma in situ) of the cervix, and intraepithelial carcinoma of other areas Within 5 years of consent date.
  • Medical history of hypersensitivity to the components of the investigational products. (The components of test drug 1 and 2, including the Rhein-based drug)
  • Patients with an allergic reaction to sulfonamide.
  • Patients with galactose intolerance, lapp lactase deficiency or glucose-galactose malabsorption.
  • Subjects who have not reached the prescribed period after receiving contraindicated medication or treatment before participation in this clinical trial.
  • Patients receiving contraindicated medication.
  • Alcohol and other drug abuse cases based on 6 months before screening.
  • Pregnant women or nursing mothers who are not willing to stop breastfeeding.
  • Female who do not fall into one or more of the following categories(In other words, only the following female can participate:)
  • (1) Menopause (non-therapy-induced amenorrhea of more than 12 months) Female
  • (2) Female infertility due to surgery (no ovaries and / or uterus)
  • (3) If you have sexual intercourse with only one male partner who has been confirmed to have no semen after fertilization.
  • (4) Female subjects who agreed to abstinence during the clinical trial period.
  • If the subject is assured of an abstinence throughout the trial period.(e.g. clergy)
  • However, intermittent abstinence (eg, contraception using ovulation period, symptothermal) or coitus interrupts is not a case of consent for abstinence.
  • (5) For women of childbearing age, the following methods or methods of contraception use the effective method of contraception to be used during the period of this clinical trial:
  • Oral contraceptive
  • The contraceptive patch
  • Intra uterine device (IUD)
  • contraceptive implant
  • contraceptive injection
  • intrauterine hormonal apparatus
  • Tubal ligation and infertility surgery
  • If 30 days have not elapsed after the date of signing of the previous clinical trial or currently participating in other clinical trials.
  • Patients who are scheduled for surgery during the clinical trial period or who have difficulties in completing the protocol during this clinical trial due to other reasons.
  • In addition to the above, other diseases that the investigator judges to be inappropriate.

Trial locations and contacts

2 sites in 1 country.

Yu-na Jo contact

82-70-4335-5448

ynjo@symyoo.com

Sung Woon Yang contact

82-31-354-0604

yangsw7@naver.com

South Korea2 sites, 2 recruiting

  • Seoul ST. Mary's Hospital

    Seoul, 06591

    Whan-Seok Choi, M.D., Ph.D., 82-2-2258-6285, fmchs@catholic.ac.kr

    Whan-Seok Choi, M.D., Ph.D

    Recruiting

  • Korea University Guro Hospital

    Seoul, 08308

    Seon-Mee Kim, MD, PhD, 82-2-2626-3276, ksmpdh@korea.ac.kr

    Seon-Mee Kim, M.D., Ph.D.

    Recruiting

Other trials in South Korea

About this study

Official title: A Prospective, Randomized, Double-blinded, Multi-center, Trial to Evaluate Efficacy and Safety of Combination of Diacerein and Celecoxib Administered Orally in Patients With Knee Osteoarthritis

The purpose of this study is to evaluate the pain relief effect of Co-administration of Diacerein with Celecoxib in patients with knee osteoarthritis compared with single administration of each drug.

Read the detailed description

A large epidemiological study in Europe reported that over four-thirds of patients with osteoarthritis received combination therapy with two or more drugs. Approximately 1.5% of patients with osteoarthritis using three or more drugs are using COX-2(Cyclo-oxygenase-2) inhibitors and SYSADOA(Symptomatic slow acting drug), And it has been investigated that much more patients are using the two classes of drugs when the range is extended to other oral NSAIDs other than COX-2 inhibitors. Therefore, considering the characteristics of patients with osteoarthritis, such as basal disease and treatment effects on each type of drug, it is important to find the optimal combination of drugs for each patient characteristics.

There is a previous study using osteoarthritis rat model as a biological basis of diacerein and celecoxib administration. Previous studies have shown that the combined use of Diacerein and Celecoxib improves osteoarthritis.

The purpose of this study is to evaluate the pain relief effect of Co-administration of Diacerein with Celecoxib in patients with knee osteoarthritis compared with single administration of each drug.

Being tested
Diacerein, Celecoxib
Keywords
Knee Osteoarthritis, Diacerein
Medical subject headings
Osteoarthritis, Knee

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DiacereinDrug

    For 12 weeks, administered twice a day by oral.

  • CelecoxibDrug

    For 12 weeks, administered twice a day by oral.

Study groups in NCT03404479
Study groupRoleWhat they receive
Co-administration groupExperimentalCo-administration of Diacerein 50mg, Celecoxib 100mg.
Receives: Drug: Diacerein; Drug: Celecoxib
Single administration group 1Active comparatorSingle administration of Diacerein 50mg and placebo.
Receives: Drug: Diacerein
Single administration group 2Active comparatorSingle administration of Celecoxib 100mg and placebo.
Receives: Drug: Celecoxib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. pain VAS score

    Changes in pain VAS(Visual analogue scale) score before and after 12 weeks of drugs administration.

    (No pain score: 0, Worst pain score: 100)

    Measured: 12 weeks after randomization

Secondary outcomes (3)

  1. pain NRS score

    Changes in pain NRS(Numeric rating scale) score before and after 12 weeks of drugs administration.

    (No pain score: 0, Worst pain score: 10)

    Measured: 12 weeks after randomization

  2. WOMAC index score

    Changes in WOMAC(Western Ontario and mcmaster Universities Osteoarthritis Index) index score before and after 12 weeks of drugs administration (possible score range, Pain: 0-20, Stiffness: 0-8, Physical function: 0-68; Total Score range: 0-96 ('none' to 'extreme'))

    Measured: 12 weeks after randomization

  3. GSRS index score

    Changes in GSRS(Gastrointestinal symptom rating scale) index score before and after 12 weeks of drugs administration.

    (Score range: 0-45 ('none' to 'extreme'))

    Measured: 12 weeks after randomization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jan 2018
  2. Study start25 Jan 2018
  3. Primary completion2 Jan 2019 (estimated)
  4. Study completion2 Jan 2019 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
90 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03404479
Sponsor's protocol ID
DIA IIT_01
Acronym
DIA IIT_01
Status last verified
Feb 2018
First submitted
12 Jan 2018
Last updated
26 Feb 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Li Z, Meng D, Li G, Xu J, Tian K, Li Y. Celecoxib Combined with Diacerein Effectively Alleviates Osteoarthritis in Rats via Regulating JNK and p38MAPK Signaling Pathways. Inflammation. 2015 Aug;38(4):1563-72. doi: 10.1007/s10753-015-0131-3.

    PubMed 25687638

  • Martel-Pelletier J, Pelletier JP. Effects of diacerein at the molecular level in the osteoarthritis disease process. Ther Adv Musculoskelet Dis. 2010 Apr;2(2):95-104. doi: 10.1177/1759720X09359104.

    PubMed 22870441

  • Panova E, Jones G. Benefit-risk assessment of diacerein in the treatment of osteoarthritis. Drug Saf. 2015 Mar;38(3):245-52. doi: 10.1007/s40264-015-0266-z.

    PubMed 25652235

  • Nicolas P, Tod M, Padoin C, Petitjean O. Clinical pharmacokinetics of diacerein. Clin Pharmacokinet. 1998 Nov;35(5):347-59. doi: 10.2165/00003088-199835050-00002.

    PubMed 9839088

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Diacerein and Celecoxib in people with Knee Osteoarthritis, run by Whan-Seok Choi at 2 sites in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 42 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 26 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Yu-na Jo (82-70-4335-5448, ynjo@symyoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

pain VAS score (time frame: 12 weeks after randomization). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03404479, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2018.

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